ISO-9001-Lead-Auditor Authorized Test Dumps | ISO-9001-Lead-Auditor Valid Cram Materials
ISO-9001-Lead-Auditor Authorized Test Dumps | ISO-9001-Lead-Auditor Valid Cram Materials
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q46-Q51):
NEW QUESTION # 46
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.
Answer:
Explanation:
NEW QUESTION # 47
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?
- A. Quality objectives were not established in alignment with the organisation's quality policy.
- B. The organisation cannot afford to undertake quality objectives all at once.
- C. Establishing quality objectives did not include top management.
- D. Quality objectives are not maintained as documented information.
- E. The consultant has not interpreted ISO 9001 correctly.
- F. Quality objectives are not being implemented by the organisations' personnel.
Answer: A,D
Explanation:
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization' s own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
NEW QUESTION # 48
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:
2015 are true?
- A. Reviews the processes with high level of risk
- B. Evaluates the results of the last management review
- C. Reviews the client's management system documented information
- D. Evaluates the conditions of all sites
- E. Verifies the degrees of customer satisfaction
- F. Verifies the compliance with legal requirements
- G. During the Stage 1 audit, the audit team:
Answer: A,C
Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit
NEW QUESTION # 49
Who assigns a guide to assist the audit team?
- A. The audit team leader
- B. The auditee
- C. The certification body
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.3 (Roles and Responsibilities of Guides and Observers):
* The auditee assigns a guide to assist the audit team.
* The guide provides logistical support, helps with navigation, and arranges access to necessary personnel and records.
* The audit team leader does not assign the guide, but they may request one.
NEW QUESTION # 50
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?
- A. Clause 8.5.6 refers to leadership and management system responsibilities.
- B. Clause 8.5.6 refers to changes during the production and service provision.
- C. Clause 8.5.6 refers to changes to legal and regulatory requirements.
- D. Clause 8.5.6 refers to changes during the design and development of products and services.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.
Clause References:
* Clause 6.3 (Planning of Changes) # Focuses on long-term changes that may impact QMS integrity.
* Clause 8.5.6 (Control of Changes) # Focuses on changes occurring during production and service provision to ensure conformity.
Why is the Correct Answer A?
* Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.
* Organizations must document who approves changes, how they are controlled, and how they affect product/service conformity.
Why are the Other Options Incorrect?
* B (Changes during design and development) # Covered under Clause 8.3 (Design and Development), not 8.5.6.
* C (Changes to legal and regulatory requirements) # Addressed under Clause 4.2 (Interested Parties
' Requirements).
* D (Leadership responsibilities) # Covered under Clause 5.1 (Leadership and Commitment), not
8.5.6.
NEW QUESTION # 51
......
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